1. Field of the Invention
This invention relates generally to surgical apparatus and methods for repair of torn tissue, and more particularly to a system, components thereof, and method for arthroscopic and other surgical repair of torn tissue and tissue reattachment by providing the system for suturing and anchoring the torn tissue together against other tissue substrates, or for attaching tissue to medical, veterinary and dental implants.
2. Description of Related Art
The rotator cuff is composed of four tendons that blend together to help stabilize and move the shoulder. When a tear occurs in the rotator cuff of the shoulder, it is often necessary to reattach the torn tendon or tendons to the bone of the humeral head. In a common prior art rotator cuff reattachment technique, the torn cuff is punctured by a punch, and prethreaded suture anchor screws (soft tissue fasteners) are drilled into the head of the humerus bone and the sutures threaded through the anchor screws are passed through the cuff in a difficult procedure using suture relay devices to pass the sutures through the tissue. After the suture strands are passed through the tissue, they are knotted and tied together to secure the reattached rotator cuff to the humerus head (knotted-technique). Other types of prior art suture anchors are cylindrically shaped members that are pressed into holes drilled into the bone and engage the cancellous mass surrounding the drilled hole and apply friction to hold the suture in place.
Many anchor/suture devices require knots to be tied, which is difficult with minimally invasive surgery and having a “knotless” solution is an advantage in these situations. It is desirable to have an engineered suture/capture construct that does not use friction to hold the suture in place, a technology employed and found in most of today's “knotless” tissue repair devices. Furthermore, a knotless device is desirable that does not crimp, crush, pinch or interfere with the suture with a friction type hold, which will avoid potential damage to the suture.
In my prior U.S. Pat. No. 6,491,714, an apparatus and method for arthroscopic repair of torn tissue such as a rotator cuff was taught wherein torn tissue such as a rotator cuff is positioned on the bone exterior by a tissue grasper. A cannula is inserted through the skin substantially to the torn tissue. A drill guide is inserted into the cannula, a drill bit is inserted into the drill guide, and a hole is drilled through the torn tissue and completely through the bone. The drill bit is removed and an inner cannula is passed through the drill guide until its distal end is engaged on the torn tissue or alternatively passed through the hole until its distal end is at the far end of the drilled hole. A soft tissue anchor having expandable wings at its distal end and sutures secured to an eyelet at its proximal end is releasably connected to the distal end of a tubular deployment tool with the free ends of the sutures extending through the deployment tool.
The deployment tool is passed through the inner cannula and a hole is drilled until the expandable wings clear the far end of the hole, a sufficient distance to allow the wings to expand to a diameter larger than the diameter of the drilled hole. The deployment tool, inner cannula, drill guide and cannula are removed and tension is applied to the suture to engage the expanded wings of the anchor on the exterior surface of the bone surrounding the drilled hole. A button is run down on the sutures through the cannula and secured on the torn tissue by the sutures such that the torn tissue is secured to the bone and the sutures are anchored to the hard exterior surface of the bone by the expanded anchor.
Unlike conventional soft tissues anchors which are anchored in the cancellous bone mass beneath the near cortex of the bone, the '714 teaching in one embodiment provides a suture anchor which is engaged on the exterior of the far cortex of the bone and completely bypasses the cancellous bone mass. The cortex of the bone is much less susceptible to osteopenia than the cancellous interior of the bone. The sutures are passed through the tissue when the anchor is set, and thus the difficult procedural step and use of devices such as punches and suture relays to pass and tie the sutures through the torn tissue is eliminated.
Calibrated markings on the '714 deployment system allow for precise measurement of the far cortex and precise measurement of the depth of insertion and engagement of the anchor device on the far cortex, such that structures beyond the cortex are not violated, and the button hold-down feature eliminates the traditionally difficult arthroscopic tying techniques.
In another broader aspect of the '714 invention, the surgical apparatus includes any form of a tissue substrate anchor of a conventional well-known structure, an elongated suture member securable at its proximal end to the anchor, and a separate torn tissue retainer which lockably engages as desired along the length of the suture member. The suture member extending through the torn tissue from the anchor and the tissue substrate. The torn tissue retainer is movable along the length of the exposed portion of the suture member until it is tightly positioned against the torn tissue and automatically locked in that position by non-reversible lockable engagement with the suture member. A separate tissue gripping member formed preferably as a semi-flexible plate or disc having a substantially larger surface area than the tissue retainer is also provided for enhanced retention of the torn tissue in place against the outer surface of the tissue substrate.
Still another broad aspect of this '714 invention is directed to a surgical apparatus which includes an integrally formed tissue substrate anchor having an elongated suture member formed as a unit therewith. A separate disc-shaped retainer lockingly engages with the exposed distal end of the suture portion at any desired point along the suture interlocking portion. The tissue retainer is therefore moveable along the length of the exposed engaging members of the suture member for tightening the tissue layer against the tissue substrate. Utilized another way, a tear such as that found within a torn meniscus may be reconnected utilizing this embodiment of the invention.
Currently, soft-tissue fixation products that utilize “knot-less” technology and screws rely on an “interference-fit” for holding power between the screw and bone. In general, non-screw anchors have a pullout strength near 200 newtons, and screws can have upwards of 400 newtons of pullout strength.
The present disclosure allows for the introduction of a revolutionary type of surgical suture system, tissue restraints and tissue anchors. Related to the original application Ser. No. 12/912,313 and furthermore following C.I.P. application Ser. No. 13/281,963, this continuation-in-part offers the final engineering of the tissue restraint/capture and defines how this system can be incorporated into medical, veterinary or dental implants of any nature, whether for tissue repair, holding tissue to an implant or for stabilizing an implant in the body.
The '963 C.I.P. introduced various improvement over the initial '313 application which were related to the tissue restraint/capture design which included, in part, various geometries that could be utilized on the entrance and exit side of the tissue restraint/capture to keep the suture from traveling in a reverse direction. This approach uses a suture with protuberances that are not deformable and the locking mechanism uses various deformations of the tissue restraint/capture. Furthermore, further suture protuberance designs were introduced that could, alone, with their specially configured protuberances, prevent reverse movement after passing through a tissue restraint/capture or in conjunction with the geometry of the tissue restraint/capture achieve this goal. In that prior approach the suture's protuberances would deform.
A revolutionary type of anchor was also introduced for soft-tissue fixation to bone, a specialized bone screw that could be utilized as a bone screw, interference screw, but, which would have the suture with its specialized deformable protuberances travel through the screws in some fashion, with the suture protuberance design preventing reverse travel through the screw. These screws were designed to optimize pull-out strength.
This present continuation-in-part introduces our latest engineering improvements in the tissue restraint/capture. While the tissue restraints/captures in the first continuation-in-part, '963 application, were deformable, allowing a suture with protuberances to pass in one direction only, we discovered that the forces needed to pull the suture through the tissue restraint would not be greatly different than the forces preventing reverse movement, i.e., either too much force was needed to pull the suture through the tissue restraint/capture or the prevention of reverse movement back through the tissue restraint/capture was too little. This latest tissue restraint/capture solves these issues with very specific parameters. In addition, this continuation-in-part describes the specific nature how this latest tissue restraint/capture can be used alone, used in multiples and can be attached to a medical, veterinary or dental implant. Based upon the present disclosure, a “pipe-line” of products will be created using knot-less, self-locking interface as a technology development platform for all types of torn medical, veterinary or dental tissue and for attaching all types of tissue to medical, veterinary or dental implants.
The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art upon a reading of the specification and a study of the drawings.